MAUDE Adverse Event Report: ANIMAS LLC ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Medical Device Problem Codes	Moisture Damage (1405); Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 30-sep-2019 with the following findings: investigation duplicated a load malfunction.The pump cover was removed and evidence of moisture corrosion was found located on the force sensor flex pins and senor housing.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.Report late due to transition from vmsr program.
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas, alleging a prime (load step malfunction) issue.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because there is the potential for insulin over delivery if the patient is not disconnected during the load cartridge step.The owner's booklet provides a warning to the user to never start the prime/rewind sequence on the pump while the infusion set is connected to the body and provides multiple reminders during the prime/rewind sequence.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 9128843
• Report Number: 2531779-2019-04948
• Device Sequence Number: 3123548
• Product Code: LZG
• UDI-Device Identifier: 10840406100976
• UDI-Public: 10840406100976
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR